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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009026
Receipt No. R000010572
Scientific Title A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma. Uncontrolled exploratory clinical study
Date of disclosure of the study information 2012/10/15
Last modified on 2012/10/02

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Basic information
Public title A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Acronym A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Scientific Title A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Scientific Title:Acronym A phase II clinical study of 5-FU and sorafenib combination therapy in patients with hepatocellular carcinoma.
Uncontrolled exploratory clinical study
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is designed to assess the efficasy and safety of combination therapy with continuous systemic 5-fluorouracil(5-FU) infusion and Sorafenib in patients with hepatocellular carcinoma(HCC) unresectable for locoregional therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes One-year survival
Key secondary outcomes OS
TTP
RR/DCR
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The combination therapy of continuous intravenous infusion of 5-FU and sorafenib
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)At least 20 years old when consent is given
2)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma found to be ineligible for resection or local treatment
3)Lesions measurable with contrast-enhanced CT or contrast-enhanced MRI
4)Child-Pugh class A
5)ECOG performance status (PS) of 0 or 1
6)Major organs functional, satisfying the following: In tests performed 14 or fewer days before enrollment:
Neutrophil count >=1500/microL
Platelet count >=50000/microL
Hemoglobin >= 8.5 g/dL
Total bilirubin < 2.0 mg/dL
Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 5 times the upper limit of the study center standard range
Serum creatinine (Cr) <=1.5 times the upper limit of the study center standard range
7)Capable of complying with requirements about visit days, medication, and laboratory tests
8)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation

Key exclusion criteria 1)History of use of Sorafenib or another molecular targeted drug
2)History of systemic chemotherapy
3)Clinically significant ascites (refractory ascites requiring drainage)
4)History of liver transplantation
5)Esophageal varices with the potential to bleed
6) Any of the following 12 or fewer months before enrollment in this research:
Myocardial infarction, unstable angina, cardiac failure, cerebrovascular disorder
7)Concurrent or prior hepatic encephalopathy
8)Brain tumor
9)On dialysis
10)Gastrointestinal hemorrhage during past month
11)Active multiple cancer
12)On a CYP3A4 inducer (rifampicin, phenobarbital, phenytoin, carbamazepine, dexamethasone) or food including St. John's wort.
13) Any of the following concurrent diseases:
Grade 2 or greater arrhythmia or poorly controlled hypertension according to the JCOG/JSCO Japanese translation of the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE v 4.0)
14)Contraindicated for any of the study drugs
15)Orally taking an herbal medicine approved for the treatment of cancer (e.g., shosaikoto)
16)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related disease
17) Otherwise found ineligible as a subject by the researcher

Target sample size 98

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Chuma
Organization Hokkaido University Hospital
Division name Department of Gastroenterogy and Hematorogy
Zip code
Address kita 14,Nishi 5,Kita-ku, Sapporo, Japan
TEL 011-716-1161(5920)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Chuma
Organization Hokkaido University Hospital
Division name Department of Gastroenterogy and Hematorogy
Zip code
Address kita 14,Nishi 5,Kita-ku, Sapporo, Japan
TEL 011-716-1161(5920)
Homepage URL
Email

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2012 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 02 Day
Last modified on
2012 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010572

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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